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    <basicUdiDi>8406821BUG00209H8</basicUdiDi>
    <tradeName>00195278473028</tradeName>
    <deviceName>Voluson S10 Expert, Voluson S10, Voluson S8t, Voluson S8, Voluson S6</deviceName>
    <manufacturerName>GE Ultrasound Korea, Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000001860</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Voluson Signature to BT22 UPG / 5881172</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:20.625Z</lastUpdated>
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    <udiDi>00195278473011</udiDi>
    <basicUdiDi>8406821BUG00210GR</basicUdiDi>
    <tradeName>00195278473011</tradeName>
    <deviceName>Voluson P8, Voluson P6</deviceName>
    <manufacturerName>GE Ultrasound Korea, Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000001860</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Voluson Performance to BT22 UPG / 5881175</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:19.811Z</lastUpdated>
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    <udiDi>00195278471277</udiDi>
    <basicUdiDi>8406821BUG00154H8</basicUdiDi>
    <tradeName>Revolution CT ES with Apex edition</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018315</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030607</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Revolution CT ES with Apex edition</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:19.013Z</lastUpdated>
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    <udiDi>00195278469700</udiDi>
    <basicUdiDi>8406821BUG00213GX</basicUdiDi>
    <tradeName>Revolution Apex Select</tradeName>
    <deviceName>Revolution Apex Select</deviceName>
    <manufacturerName>GE HANGWEI MEDICAL SYSTEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009292</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Power Xtream: B7919QT; Power Pro: B7919QS</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:18.204Z</lastUpdated>
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    <udiDi>00195278466488</udiDi>
    <basicUdiDi>8406821BUG00215H3</basicUdiDi>
    <tradeName>RT Refresh Package</tradeName>
    <deviceName>RT Refresh Package</deviceName>
    <manufacturerName>GE HANGWEI MEDICAL SYSTEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009292</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030603</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B79612DA, B79602DA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:13.392Z</lastUpdated>
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    <udiDi>00195278464668</udiDi>
    <basicUdiDi>8406821BUG00211GT</basicUdiDi>
    <tradeName>00195278464668</tradeName>
    <deviceName>LOGIQ P8, LOGIQ P9, LOGIQ P10</deviceName>
    <manufacturerName>GE Ultrasound Korea, Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000001860</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LOGIQ P10 R4.5 HD/H42932LE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:12.585Z</lastUpdated>
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    <udiDi>00195278118356</udiDi>
    <basicUdiDi>8406821BUG00192HG</basicUdiDi>
    <tradeName>Definium Tempo</tradeName>
    <deviceName>Medical Diagnostic Radiology Device</deviceName>
    <manufacturerName>GE HUALUN MEDICAL SYSTEMS CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001189</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B2401CAB</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:11.806Z</lastUpdated>
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    <udiDi>00195278070265</udiDi>
    <basicUdiDi>8406821BUG00193HJ</basicUdiDi>
    <tradeName>Definium Tempo Pro</tradeName>
    <deviceName>Medical Diagnostic Radiology Device</deviceName>
    <manufacturerName>GE HUALUN MEDICAL SYSTEMS CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001189</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B2402CAB</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:11.718Z</lastUpdated>
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    <udiDi>08057737121487</udiDi>
    <basicUdiDi>805773712FT2519P</basicUdiDi>
    <tradeName>VDX Next System 4343VW STD</tradeName>
    <deviceName>VDX Next System</deviceName>
    <manufacturerName>Villa Sistemi Medicali S.p.A.</manufacturerName>
    <manufacturerSrn>IT-PR-000027254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039021</emdnCode>
    <emdnDescription>RADIOGRAPHY VIDEO ACQUISITION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8785V05000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:14:35.788Z</lastUpdated>
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    <udiDi>08055186671010</udiDi>
    <basicUdiDi>805518667MX/1000D9</basicUdiDi>
    <tradeName>MX/1000 FP21</tradeName>
    <deviceName></deviceName>
    <manufacturerName>A.T.S. Applicazione Tecnologie Speciali s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000010734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039006</emdnCode>
    <emdnDescription>RADIOLOGY CONTROL UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93 02 000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:13:10.840Z</lastUpdated>
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    <udiDi>08055186670211</udiDi>
    <basicUdiDi>805518667FPVP</basicUdiDi>
    <tradeName>OMNISCOP DReam</tradeName>
    <deviceName></deviceName>
    <manufacturerName>A.T.S. Applicazione Tecnologie Speciali s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000010734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74 09 000-1; 74 11 000-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:13:09.235Z</lastUpdated>
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    <udiDi>08055186670150</udiDi>
    <basicUdiDi>805518667FP-SFH</basicUdiDi>
    <tradeName>FDX Visionary CS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>A.T.S. Applicazione Tecnologie Speciali s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000010734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>95 05 000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:13:08.439Z</lastUpdated>
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    <udiDi>08054890480369</udiDi>
    <basicUdiDi>805489048PENQ7</basicUdiDi>
    <tradeName>CS3101</tradeName>
    <deviceName>Stativo Pensile</deviceName>
    <manufacturerName>General Medical Merate S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000023169</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030502</emdnCode>
    <emdnDescription>CEILING STANDS FOR RADIOLOGICAL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS3101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:13:06.826Z</lastUpdated>
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    <udiDi>08054890480215</udiDi>
    <basicUdiDi>805489048TRDRE</basicUdiDi>
    <tradeName>CT160F</tradeName>
    <deviceName>Table for RAD rooms</deviceName>
    <manufacturerName>General Medical Merate S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000023169</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030503</emdnCode>
    <emdnDescription>PATIENT TABLES FOR RADIOLOGICAL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT160F</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:13:04.434Z</lastUpdated>
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    <udiDi>08054890480130</udiDi>
    <basicUdiDi>805489048TLRRQ</basicUdiDi>
    <tradeName>WST-DX</tradeName>
    <deviceName>Wall Stand units</deviceName>
    <manufacturerName>General Medical Merate S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000023169</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030506</emdnCode>
    <emdnDescription>TELERADIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WST-DX</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:13:02.829Z</lastUpdated>
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    <udiDi>08052405210043</udiDi>
    <basicUdiDi>805240521ANALOGICGV</basicUdiDi>
    <tradeName>LILYUM</tradeName>
    <deviceName>ANALOG MAMMOGRAPHY</deviceName>
    <manufacturerName>Metaltronica SpA</manufacturerName>
    <manufacturerSrn>IT-MF-000014684</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030201</emdnCode>
    <emdnDescription>CONVENTIONAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-LILYUM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:12:09.010Z</lastUpdated>
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    <udiDi>00810007560007</udiDi>
    <basicUdiDi>81000756AXS00016J</basicUdiDi>
    <tradeName>SPY-PHI Articulating Arm, Main Arm</tradeName>
    <deviceName>Atlas™ Rigid Arm, Single, 400mm, L-Column, Quick Connect- Square</deviceName>
    <manufacturerName>Axcess Surgical Innovations LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000014666</manufacturerSrn>
    <authorisedRepresentativeName>Axcess Surgical Innovations B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002697</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z119099</emdnCode>
    <emdnDescription>VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HH1001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:09:02.332Z</lastUpdated>
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    <udiDi>07350005280017</udiDi>
    <basicUdiDi>735000528SentinelG9</basicUdiDi>
    <tradeName>Sentinel 4DCT</tradeName>
    <deviceName>Sentinel 4DCT</deviceName>
    <manufacturerName>C-RAD Positioning AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022326</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z119010</emdnCode>
    <emdnDescription>LASER SYSTEMS FOR PATIENT POSITIONING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP001-0022</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:01:39.916Z</lastUpdated>
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    <basicUdiDi>73500020105HG</basicUdiDi>
    <tradeName>RayStation v2025 SP1B</tradeName>
    <deviceName>RayStation</deviceName>
    <manufacturerName>RAYSEARCH LABORATORIES AB (PUBL)</manufacturerName>
    <manufacturerSrn>SE-MF-000001908</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019082</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>17.3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:01:38.999Z</lastUpdated>
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    <udiDi>07350002010983</udiDi>
    <basicUdiDi>73500020106HJ</basicUdiDi>
    <tradeName>RayCare v2025 SP1</tradeName>
    <deviceName>RayCare</deviceName>
    <manufacturerName>RAYSEARCH LABORATORIES AB (PUBL)</manufacturerName>
    <manufacturerSrn>SE-MF-000001908</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019082</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:01:35.656Z</lastUpdated>
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